What risk level is assigned to preparations made from non-sterile ingredients?

Preparations made from non-sterile ingredients are assigned a risk level of High according to USP 797 guidelines. This classification is based on the potential for contamination due to the presence of non-sterile components. When compounding with non-sterile ingredients, there is an increased risk of introducing microorganisms into the final product, which can lead to serious infections or other adverse effects for patients.

High-risk level compounding typically involves procedures that create potential for contamination, such as mixing sterile and non-sterile ingredients, or involving multiple sterile components that may have come into contact with non-sterile surfaces or containers. This necessitates strict adherence to aseptic techniques and enhanced control measures to ensure patient safety.

In contrast, the other risk levels—Low, Medium, and Immediate-use—are defined under different conditions that typically involve sterile ingredients or limit the procedures to situations where contamination risks do not increase significantly. Therefore, the classification of High for non-sterile ingredients underscores the importance of maintaining sterility and safety in compounded preparations.